Recent trends among consumers are influencing companies to increase quality control guidelines in their quality control process. Research shows consistency and quality are leading factors among consumers. A survey by IQMS revealed that product quality is increasing in importance, bringing companies to meet higher standards in quality control. With a rise in attention to detail by consumers, companies are focusing on validation and qualification standards as a way to set themselves apart against the competition.
Validating quality control is best demonstrated by the Pharmaceutical Industry, which is regulated by the FDA. This begins by documenting the quality process from when an instrument is first installed and turned on through verifying the measurement process yields expected results. The Pharmaceutical Industry must also comply with strict guidelines referred to in 21 CFR part 11, which defines how measured data is electronically stored and protected from editing. Companies outside the Pharmaceutical Industry are starting to model their product standards similarly, by investing in these types of protocols and processes in their manufacturing operations.
In past years validation & compliance procedures were customized paper documents written for each specific instrument and application. HunterLab has created a Digital Qualification Notebook generator that simplifies the process of qualification and decreases costs significantly. Prior to digital qualification, a customer was assigned a Technical Services representative that led a lengthy interview about the intended use of the instrument. Then a handwritten custom procedure would be compiled specifically for that application. Incorporating a simple user interface, HunterLab’s Digital Qualification Notebook generator is a software-based solution that guides a customer through a simple electronic interview process to create a customized notebook with step-by-step Validation and Qualification procedures that can be used to meet any users ISO requirements.
Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are at the core of any instrument Validation and Compliance process. This qualification process is typically followed upon receipt of a new instrument and with requalification’s performed when an instrument has been moved, for example from one lab to another, or when service or repairs have been done to the instrument. This digital version of HunterLab’s original Qualification Notebook creates easy to follow printable IQ/OQ/PQ instructions and documentation. This ensures equipment is properly installed as well as performing to factory specifications, as well as meeting all measurement requirements for the users intended samples.
Extending beyond the Pharmaceutical industry, a focus on instrument validation and compliance will benefit any manufacturing company looking to improve their GMP. Digital Qualification Notebook software is the latest tool that will allow HunterLab customers a simplified way to achieve and maintain validation and compliance of their HunterLab instrument to their GMP standards.
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Author of this Blog: Dominique Lategano
Mr. Philips has spent the last 30 years in product development and management, technical sales, marketing, and business development in several industries. Today, he is the global market development manager for HunterLab, focused on understanding customer needs, providing appropriate solutions and education, and helping to solve customer color challenges across these industries and cultures.